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510(k) Data Aggregation
(371 days)
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or nonpregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The acceptance criteria for the Beckman Instruments ACCESS® Toxo IgM assay and its reported performance are described below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity (vs. predicate) | Not explicitly stated as a numerical criterion, but the context implies substantial equivalence to the predicate device, Platelia® Toxo IgM. | 96% |
| Specificity (vs. predicate) | Not explicitly stated as a numerical criterion, but the context implies substantial equivalence to the predicate device, Platelia® Toxo IgM. | 99.7% |
| Resolved Sensitivity | Not explicitly stated as a numerical criterion. | 96% (after discrepancy analysis) |
| Resolved Specificity | Not explicitly stated as a numerical criterion. | 99.7% (after discrepancy analysis) |
| Specificity (in prospective population with 1.25% prevalence) | Not explicitly stated as a numerical criterion, but relative to a consensus result in a specific population type. | 99.2% |
| Intra-assay Precision (CV) | Not explicitly stated as a numerical criterion, but typically <5% for good precision. | <5% |
| Total Imprecision (CV) | Not explicitly stated as a numerical criterion, but typically <10% for good precision. | <10% |
The study concluded that the device is "substantially equivalent to the Platelia® Toxo IgM assay currently in commercial distribution." This implies that the observed performance metrics (sensitivity, specificity, precision) were deemed acceptable in comparison to the predicate device.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 822 patient serum samples.
- Data Provenance: Not explicitly stated, but the predicate device (Platelia® Toxo IgM Sanofi Diagnostics Pasteur, Inc.) is noted as being from France. It is not specified if the samples themselves were from France or other regions, nor is it explicitly stated if the data was retrospective or prospective for the initial comparison. However, one specific performance metric is reported "In a prospective population with a prevalence of 1.25% (5/400)," indicating at least a portion of the data was prospective for that specific analysis.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document mentions "After discrepancy analysis" for resolved sensitivity and specificity. However, it does not specify the adjudication method used (e.g., 2+1, 3+1, none). The "consensus result" is mentioned for the specificity in the prospective population, suggesting some form of expert agreement or a reference standard was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study compares the performance of the ACCESS® Toxo IgM assay to a predicate device (Platelia® Toxo IgM assay), not the improvement of human readers with vs. without AI assistance.
6. Standalone Performance
Yes, the study evaluated the standalone performance of the ACCESS® Toxo IgM assay by comparing its qualitative detection of anti-Toxoplasma IgM to a legally marketed predicate device (Platelia® Toxo IgM). The reported sensitivity, specificity, and precision values are measures of its standalone analytical performance.
7. Type of Ground Truth Used
The primary ground truth for the initial comparison was the performance of the predicate device, Platelia® Toxo IgM. In a specific prospective population analysis, "a consensus result" was used as the ground truth. This suggests a combination of a comparative reference (predicate device) and potentially expert consensus for certain analyses.
8. Sample Size for the Training Set
The document does not provide information on a separate training set or its sample size. The clinical studies mentioned describe the evaluation of the device's performance against a predicate and a consensus in patient samples, which typically corresponds to a validation or test set rather than a training set for an algorithm. This is a diagnostic assay, not an AI/ML algorithm that requires a separate training set.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML algorithm (this is an immunoassay), this information is not applicable.
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